Cleared Traditional

K903193 - SMITH & NEPHEW DYONICS LEVELERT SYSTEM

K903193 is an FDA 510(k) clearance for SMITH & NEPHEW DYONICS LEVELERT SYSTEM, manufactured by Smith & Nephew Dyonics, Inc.. The device is a Class 2 General Hospital device with product code FLN cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K903193 · Smith & Nephew Dyonics, Inc. · General Hospital
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Aug 1990
Decision
42d
Days
Class 2
Risk

K903193 is an FDA 510(k) clearance for the SMITH & NEPHEW DYONICS LEVELERT SYSTEM. Classified as Monitor, Electric For Gravity Flow Infusion Systems (product code FLN), Class II - Special Controls.

Submitted by Smith & Nephew Dyonics, Inc. (Andover, US). The FDA issued a Cleared decision on August 30, 1990 after a review of 42 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2420 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smith & Nephew Dyonics, Inc. devices

FDA 510(k) Submission Details - K903193

510(k) Number K903193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1990
Decision Date August 30, 1990
Days to Decision 42 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 129d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLN Device Classification - Class 2, Special Controls

Product Code FLN Monitor, Electric For Gravity Flow Infusion Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2420
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLN Monitor, Electric For Gravity Flow Infusion Systems

All 15
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